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A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC) (CheckMate 816)

Primary Purpose

Non Small Cell Lung Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Cisplatin
Vinorelbine
Gemcitabine
Docetaxel
Pemetrexed
Carboplatin
Paclitaxel
Ipilimumab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue
  • Lung function capacity capable of tolerating the proposed lung surgery
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • Available tissue of primary lung tumor

Exclusion Criteria:

  • Presence of locally advanced, inoperable or metastatic disease
  • Participants with active, known or suspected autoimmune disease
  • Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)

Other protocol defined inclusion/exclusion criteria apply

Sites / Locations

  • Local Institution - 0121
  • Local Institution - 0081
  • Local Institution - 0025
  • Local Institution - 0007
  • Memorial Regional Hospital
  • Local Institution - 0136
  • Cancer Institute Of Florida
  • Orlando Health, Inc.
  • Indian River Medical Center
  • Northwest Georgia Oncology Center, P.C.
  • Local Institution - 0015
  • Local Institution - 0002
  • Illinois Cancer Specialists
  • Local Institution - 0171
  • Local Institution - 0170
  • Local Institution - 0186
  • University Medical Center New Orleans
  • Local Institution - 0151
  • Local Institution - 0001
  • Local Institution - 0006
  • Local Institution - 0008
  • Southcoast Center For Cancer
  • Local Institution - 0012
  • Local Institution - 0090
  • St Vincent Frontier Cancer Center
  • Comprehensive Cancer Centers of Nevada
  • Local Institution - 0009
  • Valley Hospital Luckow Pavili
  • Local Institution - 0027
  • Local Institution - 0011
  • Local Institution - 0140
  • Christ Hospital
  • MetroHealth Medical Center
  • Genesis Health Care System
  • Kaiser Permanente
  • Local Institution - 0139
  • Local Institution - 0010
  • Local Institution - 0018
  • Local Institution - 0013
  • Local Institution - 0021
  • Local Institution - 0146
  • Local Institution - 0092
  • Local Institution - 0005
  • Local Institution - 0035
  • Texas Oncology
  • Local Institution - 0153
  • Local Institution - 0106
  • Southwest Cancer Center
  • Texas Cancer Center - Sherman
  • Local Institution - 0143
  • Local Institution - 0026
  • Intermountain Medical Center
  • Southwest Regional Cancer Clinic
  • Local Institution - 0003
  • Local Institution - 0135
  • Local Institution - 0125
  • Local Institution - 0198
  • Local Institution - 0022
  • Local Institution - 0023
  • Local Institution - 0079
  • Local Institution - 0077
  • Local Institution - 0076
  • Local Institution - 0073
  • Fundacao Pio Xii Hosp Cancer De Barretos
  • Local Institution - 0075
  • Local Institution - 0095
  • Local Institution - 0138
  • Local Institution - 0017
  • Local Institution - 0052
  • Local Institution - 0016
  • Local Institution - 0161
  • Local Institution
  • Local Institution - 0156
  • Local Institution - 0190
  • Local Institution - 0192
  • Local Institution - 0175
  • Local Institution - 0193
  • Local Institution - 0166
  • Local Institution - 0179
  • Local Institution
  • Local Institution - 0159
  • Local Institution - 0180
  • Local Institution - 0160
  • Local Institution - 0178
  • Local Institution - 0163
  • Local Institution - 0189
  • Local Institution - 0183
  • Local Institution - 0182
  • Local Institution - 0165
  • Local Institution - 0059
  • Local Institution - 0112
  • Local Institution - 0060
  • Local Institution - 0064
  • Local Institution - 0061
  • Local Institution - 0113
  • Local Institution - 0058
  • Local Institution - 0062
  • Local Institution - 0019
  • Local Institution - 0122
  • Local Institution
  • Local Institution
  • Local Institution - 0068
  • Local Institution - 0080
  • Local Institution - 0070
  • Local Institution - 0066
  • Local Institution - 0067
  • Local Institution - 0131
  • Local Institution - 0118
  • Local Institution - 0111
  • Local Institution - 0110
  • Local Institution - 0109
  • Local Institution - 0147
  • Local Institution - 0133
  • Local Institution - 0123
  • Local Institution - 0148
  • Local Institution - 0108
  • Local Institution - 0127
  • Local Institution - 0119
  • Local Institution - 0132
  • Local Institution - 0126
  • Local Institution - 0120
  • Local Institution - 0124
  • Local Institution - 0097
  • Local Institution - 0098
  • Local Institution - 0105
  • Local Institution - 0050
  • Local Institution - 0051
  • Local Institution - 0069
  • Local Institution - 0028
  • Local Institution - 0029
  • Local Institution - 0031
  • Local Institution - 0102
  • Local Institution - 0107
  • Local Institution - 0099
  • Local Institution - 0100
  • Local Institution - 0093
  • Local Institution - 0084
  • Local Institution - 0115

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Platinum doublet chemotherapy

Nivolumab plus platinum doublet chemotherapy

Nivolumab plus Ipilimumab

Arm Description

Specified dose on specified days

Specified dose on specified days

Specified dose on specified days

Outcomes

Primary Outcome Measures

Event-Free Survival (EFS)
Event-free survival (EFS) is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on blinded independent central review (BICR) assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Pathologic Complete Response (pCR) Rate
Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR).

Secondary Outcome Measures

Major Pathologic Response (MPR) Rate
Major pathologic response (MPR) rate is defined as number of randomized participants with </= 10% residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR). Viable tumors in situ carcinoma should not be included in MPR calculation.
Overall Survival (OS)
Overall survival (OS) is defined as the time between the date of randomization and the date of death. OS will be censored on the last date a participant was known to be alive.
Time to Death or Distant Metastases (TTDM)
TTDM is defined as the time between the date of randomization and the first date of distant metastasis or the date of death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is outside of the thorax using blinded independent central review (BICR) according to response evaluation criteria in solid tumors (RECIST) 1.1. Patients who have not developed distant metastasis or died at the time of analysis will be censored on the date of their last evaluable tumor assessment.

Full Information

First Posted
December 16, 2016
Last Updated
October 12, 2023
Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02998528
Brief Title
A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)
Acronym
CheckMate 816
Official Title
Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 4, 2017 (Actual)
Primary Completion Date
September 8, 2021 (Actual)
Study Completion Date
November 8, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC. This study has multiple primary endpoints.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
505 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Platinum doublet chemotherapy
Arm Type
Active Comparator
Arm Description
Specified dose on specified days
Arm Title
Nivolumab plus platinum doublet chemotherapy
Arm Type
Experimental
Arm Description
Specified dose on specified days
Arm Title
Nivolumab plus Ipilimumab
Arm Type
Experimental
Arm Description
Specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
BMS-936558, Opdivo
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
BMS-734016, Yervoy
Intervention Description
This arm is closed and no longer enrolling patients.
Primary Outcome Measure Information:
Title
Event-Free Survival (EFS)
Description
Event-free survival (EFS) is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on blinded independent central review (BICR) assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Time Frame
From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)
Title
Pathologic Complete Response (pCR) Rate
Description
Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR).
Time Frame
From randomization up to a median of 30 months after randomization.
Secondary Outcome Measure Information:
Title
Major Pathologic Response (MPR) Rate
Description
Major pathologic response (MPR) rate is defined as number of randomized participants with </= 10% residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR). Viable tumors in situ carcinoma should not be included in MPR calculation.
Time Frame
From randomization up to a median of 30 months after randomization.
Title
Overall Survival (OS)
Description
Overall survival (OS) is defined as the time between the date of randomization and the date of death. OS will be censored on the last date a participant was known to be alive.
Time Frame
From randomization to the date of death
Title
Time to Death or Distant Metastases (TTDM)
Description
TTDM is defined as the time between the date of randomization and the first date of distant metastasis or the date of death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is outside of the thorax using blinded independent central review (BICR) according to response evaluation criteria in solid tumors (RECIST) 1.1. Patients who have not developed distant metastasis or died at the time of analysis will be censored on the date of their last evaluable tumor assessment.
Time Frame
From randomization to the first date of distant metastasis or the date of death in the absence of distant metastasis (Up to a median of 30 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue Lung function capacity capable of tolerating the proposed lung surgery Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 Available tissue of primary lung tumor Exclusion Criteria: Presence of locally advanced, inoperable or metastatic disease Participants with active, known or suspected autoimmune disease Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors) Other protocol defined inclusion/exclusion criteria apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0121
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Local Institution - 0081
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Local Institution - 0025
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Local Institution - 0007
City
Plainville
State/Province
Connecticut
ZIP/Postal Code
06062
Country
United States
Facility Name
Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33201
Country
United States
Facility Name
Local Institution - 0136
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Cancer Institute Of Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Orlando Health, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Indian River Medical Center
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Northwest Georgia Oncology Center, P.C.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Local Institution - 0015
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Local Institution - 0002
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Illinois Cancer Specialists
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Local Institution - 0171
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Local Institution - 0170
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Local Institution - 0186
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University Medical Center New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Local Institution - 0151
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Local Institution - 0001
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Local Institution - 0006
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 0008
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Southcoast Center For Cancer
City
Fairhaven
State/Province
Massachusetts
ZIP/Postal Code
02719
Country
United States
Facility Name
Local Institution - 0012
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2608
Country
United States
Facility Name
Local Institution - 0090
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
St Vincent Frontier Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Local Institution - 0009
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Valley Hospital Luckow Pavili
City
Westwood
State/Province
New Jersey
ZIP/Postal Code
07675
Country
United States
Facility Name
Local Institution - 0027
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Local Institution - 0011
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Local Institution - 0140
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Genesis Health Care System
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Kaiser Permanente
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Local Institution - 0139
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Local Institution - 0010
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Local Institution - 0018
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Local Institution - 0013
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Local Institution - 0021
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Local Institution - 0146
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Local Institution - 0092
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Local Institution - 0005
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Local Institution - 0035
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Texas Oncology
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Local Institution - 0153
City
Fort Bliss
State/Province
Texas
ZIP/Postal Code
79918
Country
United States
Facility Name
Local Institution - 0106
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Southwest Cancer Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79415
Country
United States
Facility Name
Texas Cancer Center - Sherman
City
Sherman
State/Province
Texas
ZIP/Postal Code
75090-0504
Country
United States
Facility Name
Local Institution - 0143
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Local Institution - 0026
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Southwest Regional Cancer Clinic
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
Local Institution - 0003
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Local Institution - 0135
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
Local Institution - 0125
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Local Institution - 0198
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22408
Country
United States
Facility Name
Local Institution - 0022
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Local Institution - 0023
City
Ciudad Autonoma De Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
1181
Country
Argentina
Facility Name
Local Institution - 0079
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
70200-730
Country
Brazil
Facility Name
Local Institution - 0077
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-090
Country
Brazil
Facility Name
Local Institution - 0076
City
Ijui
State/Province
RIO Grande DO SUL
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Local Institution - 0073
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Fundacao Pio Xii Hosp Cancer De Barretos
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Local Institution - 0075
City
Rio de Janeiro
ZIP/Postal Code
22793-080
Country
Brazil
Facility Name
Local Institution - 0095
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8P 7H2
Country
Canada
Facility Name
Local Institution - 0138
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Local Institution - 0017
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Local Institution - 0052
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 3R9
Country
Canada
Facility Name
Local Institution - 0016
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Local Institution - 0161
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Local Institution
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Local Institution - 0156
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Local Institution - 0190
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510095
Country
China
Facility Name
Local Institution - 0192
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Local Institution - 0175
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Local Institution - 0193
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Local Institution - 0166
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Local Institution - 0179
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Local Institution
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
Local Institution - 0159
City
XiAn
State/Province
Shan1xi
ZIP/Postal Code
710061
Country
China
Facility Name
Local Institution - 0180
City
Xian
State/Province
Shan3xi
ZIP/Postal Code
710038
Country
China
Facility Name
Local Institution - 0160
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Local Institution - 0178
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Local Institution - 0163
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Local Institution - 0189
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Local Institution - 0183
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Local Institution - 0182
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Local Institution - 0165
City
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Local Institution - 0059
City
Marseille Cedex 20
ZIP/Postal Code
13915
Country
France
Facility Name
Local Institution - 0112
City
Paris Cedex 5
ZIP/Postal Code
75248
Country
France
Facility Name
Local Institution - 0060
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Local Institution - 0064
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Local Institution - 0061
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
Local Institution - 0113
City
Strasbourg
ZIP/Postal Code
67100
Country
France
Facility Name
Local Institution - 0058
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution - 0062
City
Tours Cedex 09
ZIP/Postal Code
37044
Country
France
Facility Name
Local Institution - 0019
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Local Institution - 0122
City
Thessaloniki
ZIP/Postal Code
57001
Country
Greece
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Local Institution
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Local Institution - 0068
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Local Institution - 0080
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Local Institution - 0070
City
Perugia
ZIP/Postal Code
06129
Country
Italy
Facility Name
Local Institution - 0066
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
Local Institution - 0067
City
Roma
ZIP/Postal Code
00149
Country
Italy
Facility Name
Local Institution - 0131
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4640021
Country
Japan
Facility Name
Local Institution - 0118
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
2778577
Country
Japan
Facility Name
Local Institution - 0111
City
Kitakyushu-shi
State/Province
Fukuoka
ZIP/Postal Code
8078555
Country
Japan
Facility Name
Local Institution - 0110
City
Fukushima-shi
State/Province
Fukushima
ZIP/Postal Code
9601295
Country
Japan
Facility Name
Local Institution - 0109
City
Hiroshima-Shi
State/Province
Hiroshima
ZIP/Postal Code
7348551
Country
Japan
Facility Name
Local Institution - 0147
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
0030804
Country
Japan
Facility Name
Local Institution - 0133
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
6500047
Country
Japan
Facility Name
Local Institution - 0123
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
2418515
Country
Japan
Facility Name
Local Institution - 0148
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
9800873
Country
Japan
Facility Name
Local Institution - 0108
City
Osaka-sayama-shi
State/Province
Osaka
ZIP/Postal Code
5898511
Country
Japan
Facility Name
Local Institution - 0127
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
5418567
Country
Japan
Facility Name
Local Institution - 0119
City
Sakai-shi
State/Province
Osaka
ZIP/Postal Code
5918555
Country
Japan
Facility Name
Local Institution - 0132
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
4118777
Country
Japan
Facility Name
Local Institution - 0126
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
1138431
Country
Japan
Facility Name
Local Institution - 0120
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
1600023
Country
Japan
Facility Name
Local Institution - 0124
City
Tokyo
ZIP/Postal Code
1138603
Country
Japan
Facility Name
Local Institution - 0097
City
Busan
ZIP/Postal Code
49267
Country
Korea, Republic of
Facility Name
Local Institution - 0098
City
Hwasun
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Local Institution - 0105
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Local Institution - 0050
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Facility Name
Local Institution - 0051
City
Romania
ZIP/Postal Code
400015
Country
Romania
Facility Name
Local Institution - 0069
City
Sector 2
ZIP/Postal Code
022328
Country
Romania
Facility Name
Local Institution - 0028
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution - 0029
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution - 0031
City
Majadahonda - Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Local Institution - 0102
City
New Taipei City
ZIP/Postal Code
235
Country
Taiwan
Facility Name
Local Institution - 0107
City
Taichung
ZIP/Postal Code
407219
Country
Taiwan
Facility Name
Local Institution - 0099
City
Taipei
ZIP/Postal Code
11031
Country
Taiwan
Facility Name
Local Institution - 0100
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Local Institution - 0093
City
Adana
ZIP/Postal Code
01060
Country
Turkey
Facility Name
Local Institution - 0084
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Local Institution - 0115
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
35403841
Citation
Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. doi: 10.1056/NEJMoa2202170. Epub 2022 Apr 11.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)

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